Device Classification Name |
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
|
510(k) Number |
K904473 |
Device Name |
KRONNER MANIPUJECTOR |
Applicant |
UNIMAR, INC. |
475 DANBURY RD. |
WILTON,
CT
06897
|
|
Applicant Contact |
EDWARD C VOLLMER |
Correspondent |
UNIMAR, INC. |
475 DANBURY RD. |
WILTON,
CT
06897
|
|
Correspondent Contact |
EDWARD C VOLLMER |
Regulation Number | 884.1300
|
Classification Product Code |
|
Date Received | 10/01/1990 |
Decision Date | 12/14/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|